Enlicitide Decanoate Clinical Trials (2026): 28 Studies for Healthy & Hypercholesterolemia

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

28 Enlicitide Decanoate clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Healthy & Hypercholesterolemia) and 22,873 total planned enrollment. 6 Phase 3 Enlicitide Decanoate trials are listed. 3 Enlicitide Decanoate clinical trials are actively recruiting at 19 U.S. sites across 14 states. Most recent activity: NCT07058077 (Jan 2037).

Where to Participate: All Enlicitide Decanoate Trial Sites in the U.S. (19 sites across 14 states)

Every actively recruiting Enlicitide Decanoatetrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
ALCentral Research Associates ( Site 0009)Birmingham35205NCT07216482Map
ALG&L Research ( Site 0024)Foley36535NCT07216482Map
AZCelerion ( Site 0001)Tempe85283NCT07300280Map
CAChemidox Clinical Trials ( Site 0008)Lancaster93534NCT07216482Map
CAClinical Trials Research ( Site 0036)Sacramento95821NCT07216482Map
COLegacy Clinical Trials ( Site 0044)Colorado Springs80909NCT07216482Map
DENemours/Alfred I. duPont Hospital for Children ( Site 0001)Wilmington19803NCT07058077Map
DCChildren's National Medical Center ( Site 0015)Washington D.C.20010NCT07058077Map
FLExcel Medical Clinical Trials ( Site 0008)Boca Raton33434NCT07058077Map
FLSoffer Health Institute ( Site 0046)Hollywood33020NCT07216482Map
FLClinical Site Partners LLC, dba CSP Orlando ( Site 0014)Winter Park32789NCT07216482Map
GAChildren's Healthcare of Atlanta Cardiology ( Site 0026)Atlanta30329NCT07058077Map
KYMonroe Biomedical Research ( Site 0004)Louisville40213NCT07216482Map
NVJubilee Clinical Research ( Site 0031)Las Vegas89106NCT07216482Map
OHCincinnati Children's Hospital Medical Center ( Site 0016)Cincinnati45229NCT07058077Map
TXProvecta Research Network LLC ( Site 0022)Houston77027NCT07216482Map
TXClinical Trials of Texas, Inc. ( Site 0010)San Antonio78229NCT07216482Map
VANational Clinical Research, Inc ( Site 0028)Richmond23294NCT07216482Map
WVWest Virginia University ( Site 0013)Morgantown26506NCT07058077Map

Enlicitide Decanoate clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedTotal
P112021
P2/P311
P31236

Recruiting Enlicitide Decanoate clinical trials (3)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07058077MK-0616-029A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)P2/P3Heterozygous Familial Hypercholesterolemia (HeFH)153Aug 2025
NCT07216482MK-0616-037A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)P3Hyperlipidemia975Nov 2025
NCT07300280MK-0616-039A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)P1Healthy60Dec 2025

Enlicitide Decanoate clinical trials by indication

Healthy (18)

NCTAcronymPhaseStatusTitle
NCT07300280MK-0616-039P1recruitingA Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)
NCT07481708MK-0616P1completedA Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)
NCT07044479MK-0616-040P1completedA Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)
NCT06643377MK-0616-032P1completedA Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
NCT06880874MK-0616P1completedA Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)
NCT06719544MK-0616-034P1completedA Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)
NCT06609512MK-0616-033P1completedA Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
NCT06597760MK-0616-031P1completedA Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)
+ 10 more, see All trials below.

Hypercholesterolemia (4)

NCTAcronymPhaseStatusTitle
NCT06492291MK-0616-019P3active not recruitingOpen-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
NCT05952856MK-0616-013P3completedA Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
NCT05952869P3completedA Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCT06450366P3completedA Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

Hyperlipidemia (1)

NCTAcronymPhaseStatusTitle
NCT07216482MK-0616-037P3recruitingA Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

Heterozygous Familial Hypercholesterolemia (HeFH) (1)

NCTAcronymPhaseStatusTitle
NCT07058077MK-0616-029P2/P3recruitingA Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Hepatic Insufficiency (1)

NCTAcronymPhaseStatusTitle
NCT06575959MK-0616-030P1completedA Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Arteriosclerosis (1)

NCTAcronymPhaseStatusTitle
NCT06008756MK-0616-015P3active not recruitingEnlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Hypercholesterolaemia (1)

NCTAcronymPhaseStatusTitle
NCT05934292MK-0616-020P1completedEnlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Moderate Renal Impairment (1)

NCTAcronymPhaseStatusTitle
NCT05070390MK-0616-007P1completedA Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

Enlicitide Decanoate pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
MK-0616-015NCT06008756P3active not recruitingArteriosclerosis14,550
MK-0616-019NCT06492291P3active not recruitingHypercholesterolemia3,000
MK-0616-037NCT07216482P3recruitingHyperlipidemia975
MK-0616-013NCT05952856P3completedHypercholesterolemia2,912PMID 41879224

All Enlicitide Decanoate trials (28)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07058077MK-0616-029A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)P2/P3recruiting153Merck Sharp & Dohme LLCAug 2025
NCT06008756MK-0616-015Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef OutcomesP3active not recruiting14,550Merck Sharp & Dohme LLCOct 2023
NCT06492291MK-0616-019Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef ExtensionP3active not recruiting3,000Merck Sharp & Dohme LLCAug 2024
NCT07216482MK-0616-037A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)P3recruiting975Merck Sharp & Dohme LLCNov 2025
NCT07300280MK-0616-039A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)P1recruiting60Merck Sharp & Dohme LLCDec 2025
NCT07481708MK-0616A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)P1completed30Merck Sharp & Dohme LLCMar 2026
NCT07044479MK-0616-040A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)P1completed60Merck Sharp & Dohme LLCJul 2025
NCT05952856MK-0616-013A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef LipidsP3completed2,912Merck Sharp & Dohme LLCAug 2023
NCT06643377MK-0616-032A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)P1completed27Merck Sharp & Dohme LLCNov 2024
NCT06880874MK-0616A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)P1completed40Merck Sharp & Dohme LLCApr 2025
NCT06575959MK-0616-030A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)P1completed20Merck Sharp & Dohme LLCSep 2024
NCT05952869A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)P3completed303Merck Sharp & Dohme LLCAug 2023
NCT06450366A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)P3completed301Merck Sharp & Dohme LLCJul 2024
NCT06719544MK-0616-034A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)P1completed16Merck Sharp & Dohme LLCJan 2025
NCT06609512MK-0616-033A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)P1completed20Merck Sharp & Dohme LLCOct 2024
NCT06597760MK-0616-031A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)P1completed24Merck Sharp & Dohme LLCOct 2024
NCT06625814MK-0616A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)P1completed28Merck Sharp & Dohme LLCJul 2024
NCT06772792MK-0616A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)P1completed36Merck Sharp & Dohme LLCApr 2024
NCT06772779MK-0616A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)P1completed36Merck Sharp & Dohme LLCApr 2024
NCT06699329MK-0616A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)P1completed38Merck Sharp & Dohme LLCJan 2024
NCT06691906MK-0616A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)P1completed40Merck Sharp & Dohme LLCMar 2024
NCT05934292MK-0616-020Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)P1completed33Merck Sharp & Dohme LLCJul 2023
NCT06655311MK-0616A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)P1completed56Merck Sharp & Dohme LLCSep 2022
NCT06699355MK-0616A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)P1completed18Merck Sharp & Dohme LLCNov 2023
NCT06658652MK-0616The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)P1completed34Merck Sharp & Dohme LLCOct 2023
NCT06658626MK-0616-016A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)P1completed8Merck Sharp & Dohme LLCMar 2023
NCT06814106MK-0616A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)P1completed37Merck Sharp & Dohme LLCMar 2023
NCT05070390MK-0616-007A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)P1completed18Merck Sharp & Dohme LLCNov 2021

Enlicitide Decanoate clinical trials: frequently asked questions

How many Enlicitide Decanoate clinical trials are there?
28 Enlicitide Decanoate clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 23 are marked completed.
Are Enlicitide Decanoate clinical trials recruiting in 2026?
Yes — 3 Enlicitide Decanoate trials are actively recruiting in 2026, with 19 U.S. sites across 14 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Enlicitide Decanoate being studied for?
Enlicitide Decanoate is being studied for Healthy, Hypercholesterolemia, Familial Hypercholesterolemia, Hypercholesterolaemia, Hyperlipidemia and 6 more. The trials are grouped by indication on this page.
What phase is Enlicitide Decanoate in?
Enlicitide Decanoate clinical trials span 6 Phase 3, 21 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Enlicitide Decanoate clinical trials?
The lead sponsor across the most Enlicitide Decanoate trials is Merck Sharp & Dohme LLC. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Enlicitide Decanoateas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed .

Related pages on Hipa.ai: